Evaluation Effectiveness of electro muscle stimulation and electro acupuncture in Reducing Pain and Improving the Performance of Patients with lumbar disk problem
Evaluation of efficacy of electro acupuncture and electro muscle stimulation in patients with chronic lumbar disc herniation
Design
Parallel Randomized Control Trial
Settings and conduct
Patients divided to three group .The place of work is sports medicine clinic of Imam Hossein hospital in Tehran. The first group is given that exercise with electroacupuncture.The SDZ-2 is operated for 15 minutes using an electro-puncture needle.three sessions per week for 12 sessions.the second group will do electrical muscle stimulation with veinoplus plus that exercise.The pads attach vertically to the paraspinal muscles in the L4-L5-S1 vertebrae.The third group is given exercise only. Pain score and Quebec questionnaire were completed by the patient at the beginning, at the end of the 12 sessions and after three months of the last session
Participants/Inclusion and exclusion criteria
A history of low back pain associated with degenerative intervertebral disc disease (bulging, mild protrusion) with neurologic diagnosis after examination and with pain lasting at least three months
Intervention groups
All three groups receive acetaminophen for their pain at a dose of 500 mg every 8 hours in case of severe pain. In addition, all patients will receive 8 exercises to strengthen core muscles and improve flexibility.exercise included: Pelvic bridge ، Side bridge ، curl-up ، quadruped positions ، alternate arm/leg raises ، Prone plank ، cate and camel , priformis stretch
the first group:exercise with electroacupucture
the second group:exersice with electrical muscle stimulation
the third group:just exersice
Main outcome variables
age;gender;smoking;alcohol;duration;comorbid disease;Severity of pain ; Severity of disability; BMI
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190826044615N1
Registration date:2019-11-09, 1398/08/18
Registration timing:registered_while_recruiting
Last update:2019-11-09, 1398/08/18
Update count:0
Registration date
2019-11-09, 1398/08/18
Registrant information
Name
Zeinab Faraji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8807 5911
Email address
zfaraji95@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-22, 1398/07/30
Expected recruitment end date
2019-11-21, 1398/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation Effectiveness of electro muscle stimulation and electro acupuncture in Reducing Pain and Improving the Performance of Patients with lumbar disk problem
Public title
Evaluation Effectiveness of electro muscle stimulation and electro acupuncture in Reducing Pain and Improving the Performance of Patients with lumbar disk problem
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
all patients with radicular low back pain that begins 3 months ago
patients older than 18 years
Exclusion criteria:
all patients with non radicular low back pain
patients under 18 years old
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The block randomization method is used to balance the number of samples. There are 6 different modes for triple blocks.Accordingly, patients are divided into 3 groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
2th floor no.8 6th tohid darya blv. shahrak gharb
City
tehran
Province
Tehran
Postal code
1466976413
Approval date
2018-10-28, 1397/08/06
Ethics committee reference number
IR.SBMU.MSP.REC.1397.537
Health conditions studied
1
Description of health condition studied
chronic low back pain
ICD-10 code
M51.16
ICD-10 code description
Intervertebral disc disorders with radiculopathy, lumbar region
Primary outcomes
1
Description
low back pain
Timepoint
Baseline-- End of treatment session-Three months after the end of the intervention
Method of measurement
The Quebec Back Pain Disability Scale- Visual Analogue Scale) VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group(1):Performed using SDZ-2 and electro-puncture needles for a 15 minute period. Each session will take 15 minutes and three sessions per week for 12 sessions. 10 Probes Attach to Five Lead Bytes of Polarity Frequencies of stimulation will be close to pain tolerance-Intervention The first group in addition to the intervention received the exercises described in the previous sections.
Category
Rehabilitation
2
Description
Intervention group: group(2):This will be done using the veinoplus device. The pads are attached vertically to the paraspinal muscles in the L4-L5-S1 vertebrae.In addition, they receive exercise intervention